NCT01696110·Phase 4·INTERVENTIONAL

BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.

Bivalirudin Other Completed

Status

Completed

Phase

Phase 4

Enrollment

2,194

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

Full detailed description

This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 2100 AMI patients undergoing percutaneous coronary intervention (PCI) to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

Interventions

Treatment arms and agents.

DRUG

Bivalirudin

Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.

DRUG

heparin

heparin monotherapy

DRUG

heparin plus tirofiban

combined use of heparin and tirofiban during PCI

Timeline

From registration to results.

First posted
Sep 28, 2012
Study start
Aug 2012
Primary completion
Jul 2013
Study completion
Jul 2014
Results posted
Not reported
Registry updated
Oct 1, 2014

Outcomes

What the study measures.

Primary outcomes

Net Adverse Clinical Events

Time frame · 30 days

A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings

Secondary outcomes

Net adverse clinical events

Time frame · 1 year

a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings

any bleedings (BARC class)

Time frame · 30 day

including all BARC class (class 1-5)

Major adverse cardiac and cerebral events (MACCE)

Time frame · 30 days and 1 year

a composite of all cause death, reinfarction, target vessel revascularization or stroke

Eligibility

Who can take part.

Minimum age: 18 Years
Maximum age: 80 Years
Sex: ALL
Healthy volunteers: No

Inclusion Criteria: 1. Age 18 to 80 years old 2. Planned emergency PCI for acute myocardial infarction (STEMI or NSTEMI) Symptom onset within 12h for STEMI (or within 24 h for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) Symptom onset within 72h for NSTEMI 3. Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure. 4. Provide written informed consent. Exclusion Criteria: 1. Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock. 2. Any anticoagulant agents were used 48 h before randomization. 3. Active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc.; 4. Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.), 5. Deep puncture or major surgery (including eye or brain surgery) within 1 month. 6. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis. 7. Untreated or uncontrolled hypertension \> 180/110 mmHg. 8. Hemoglobin \< 100 g/L or platelet count \< 100 \* 109 / L. 9. Elevated AST, ALT level higher than three times of the normal upper limit. 10. severe renal insufficiency (eGFR \< 30 mL/min / 1.73 m2). 11. Heparin induced thrombocytopenia. 12. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. 13. Pregnancy or lactation. 14. Researchers think that doesn't fit to participate in this study.

Study locations

81 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

1 st Hosp. of Anhui Med Univ.

Hefei, Anhui, China

Anhui Provincial Hosp.

Hefei, Anhui, China

3rd Hosp. of Beijing Univ.